A Pragmatic Guide for Migrating Investigator Sites to ICH E6(R3)

This new report focuses on what sites need to do as their teams roll up their sleeves and convert their policies, checklists, quality improvement tools, and operations from ICH E6(R2) to R3.

The clinical research landscape is evolving—and so are the standards that guide it. ICH E6(R3) brings significant updates to Good Clinical Practice, and investigator sites need practical guidance to stay ahead.

Rather than a broad overview, A Pragmatic Guide for Migrating Investigator Sites to ICH E6(R3) cuts through the complexity of the new guideline and zeroes in on what matters most for site operations: updating procedures, refining processes, and embracing technology to align with R3 requirements.

• Stay compliant and competitive with clear explanations of what’s changed and why it matters
• Gain guidance for implementing micro-level changes without major infrastructure overhauls
• Get actionable strategies for informed consent, delegation, records management, and electronic systems
• Navigate the transition confidently with insights on sponsor collaboration, budgeting, and data governance

Clinical research professionals will be better equipped to ensure compliance, advocate for pragmatic solutions, and maintain operational excellence as the industry evolves.

Download Your Guide >

Even if you don’t work at a site, understanding how sites must adapt under ICH E6(R3) gives sponsors, CRO teams, IRBs, and other stakeholders a strategic advantage in designing, managing, and supporting studies. This guide gives you the practical, site-level lens you need to make smarter decisions across the entire trial lifecycle.

This report was produced in partnership by the Association of Clinical Research Professionals (ACRP) and the Society for Clinical Research Sites (SCRS).